Shave Margins in Breast Conservation Therapy

Stopped early · Phase 2

Conditions studied: Breast Cancer, Cancer of Breast, Cancer of the Breast

In brief

The investigators propose a randomized controlled superiority trial of standard breast-conserving surgery (BCS) versus BCS with cavity shave margins (CSM). The main objectives of this trial will be to evaluate prospectively the impact of routine standardized CSM on margin status following primary surgery for early stage breast cancer (Stage 0 - II), on post-operative patient satisfaction and cosmetic outcomes, and on general intraoperative time and operative costs. A parallel group format will be implemented to compare this modified surgical therapy - BCS with CSM - with BCS alone, which is the current standard of care.

Key facts

Study ID

NCT02462200

Run by

Washington University School of Medicine

People needed

81

Starts

2016-06-13

Expected to finish

2019-11-27

Last updated by the study team

2020-06-25

Who can join

Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed, biopsy-proven stage 0-II breast cancer.
• Planning to undergo breast-conserving surgery.
• At least 18 years of age and no more than 85 years of age.
• Female.
• Able to understand and willing to sign an IRB-approved written informed consent document.

You may not qualify if…

• Prior surgical treatment for this diagnosis.
• Undergone neoadjuvant chemotherapy.
• History of prior chest radiation therapy.
• Known metastatic disease.
• Pregnant.
• Preference for mastectomy instead of breast-conserving surgery.
• History of ipsilateral breast cancer.
• Goggle assessment substudy: Iodine or seafood allergies.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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